Timeline regard Bayh-Dole march-in right requests

For a general timeline of the Bayh-Dole Act, see this page.

1980. December 12. The Bayh-Dole Act was enacted into law as part of Public Law 96-517, including Section 203 that provide march-in rights.

1984. November 8. The Bayh-Dole statute was amended by Public Law 98-620. The Public Law 98-620, amendments added a new paragraph to Section 203 to establish an administrative and judicial right of appeal, and a stay pending the exhaustion of appeals or petitions.

1997. March 3. Lloyd N. Cutler and Birch Bayh submit a march-in request to HHS Secretary Donna Shalala on behalf of CellPro over a medical device patents held by Johns Hopkins, infringed by Cellpro’s Ceprate product. This is a list of documents from the case, which are available here. The request by Lloyd N. Cutler and Birch Bayh states the following about “unreasonably high royalties (and prices of medical care)”:

Moreover, investigation may be needed to determine whether the royalty “layering” that plainly exists in the present case — where federal grantee Johns Hopkins has licensed to Becton Dickinson, which apparently marked up the price and relicensed to Baxter, which in turn clearly marked up the price and relicensed to Systemix and Applied Immune Systems — is a common problem that leads to unreasonably high royalties (and prices of medical care) that should be dealt with by regulation.

1997. August 1. NIH Director Harold Varmus, M.D, rejects the CellPro march-in petition filed by Lloyd N. Cutler and Birch Bayh on March 3, 1997.

1999. Ventana Medical Systems, Inc (now a division of Roche Diagnostics) filed a march-in request to the U.S. Department of Energy over a patent held by the University of California, licensed to Vysis. The patent was related to blocking DNA which is used in most in-situ hybridization (ISH) assays to chromosomal DNA. The parties settled the dispute, after a 30-month fact-finding process determination with DOE, with the Ventana/Roche obtaining a license.

1999. February 16. Access to Treatment, a Thai NGO, wrote a letter to HHS Secretary Donna Shalala asking for a review of the pricing of ddI, a treatment for HIV that was invented by NIH researchers and licensed to BMS. Access to Treatment wanted HHS to grant Thailand the right to manufacture generic versions of the drug.

1999. April 20. Dana Delman, a Policy Analyst for the US FDA Executive Secretariat, sends a letter rejecting the ddI request filed by Access to Treatment on February 16, 1999.

2001. September 5. The NIH used its authority to use march-in and royalty-free rights over patents on stem cell lines resulting from publicly funded research and held by the Wisconsin Alumni Foundation (WARF) as leverage to secure an open license on those patents. The NIH press release on this case is available here and the agreement between the NIH and Wicel is available here.

2004. January 29. Essential Inventions submit a march-in request to the HHS Secretary Tommy Thompson over six patents related to ritonavir, a HIV drug marketed by Abbott under the brand name Novir.

2004. January 29. Essential Inventions submit a march-in request to HHS Secretary Tommy Thompson over a patent related to latanoprost, a glaucoma drug marketed by Pfizer under the brand name Xalatan.

2004. March 10. Essential Inventions requests hearing on the ritonavir march-in rights requests.

2004. March 27. Rep. Sherrod Brown sends letter to Elias Zerhouni, M.D., Director of the NIH, explaining that “there is no legal barrier to holding a hearing […]” before making a recommendation to the Secretary on the ritonavir march-in request filed by Essential Inventions.

2004. May 25. The NIH holds a public hearing on the ritonavir march-in right request. To this date, this is the only public hearing the NIH has held on a march-in rights request. The statement submitted by James Love is available here. The agenda of the hearing and other written comments, including written comments submitted by Birch Bayh, are available here.

2004. July 29. NIH Director Elias Zerhouni rejects the ritonavir march-in request filed on January 29, 2004 by Essential Inventions.

2004. September 17. NIH Director Elias Zerhouni rejects the latanoprost march-in request filed on January 29, 2004 by Essential Inventions.

2006. The Centers for Disease Control threatened to use march-in rights to issue compulsory licenses on patents on reverse genetics, which are needed to manufacture vaccines for avian flu.

2007. February 12. KEI submit a march-in right request to the FTC over patents related to emtricitabine, a HIV drug marketed by Gilead under the brand name Emtriva, for the anti-competitive terms of its voluntary licenses to developing country manufacturers.

2007. The FTC declined to decide the march-in case filed by KEI on February 12, 2007, on the grounds that -because the Gilead voluntary license applied to developing countries- the harm was to U.S. taxpayers, not U.S. consumers, and harms caused to U.S. taxpayers for the misuse of publicly-funded inventions is not a cause of action in an U.S. antitrust case.

2010. August 2. Three Fabry disease patients, Joseph Carik, Anita Hochendoner and Anita Bova, represented by the Law Office of C. Allen Black, Jr., Ph.D., submit a march-in request to the HHS Secretary Kathleen Sebelius over patents covering agalsidase beta, a drug marketed by Genzyme under the brand name Fabrazyme. The cover letter is here and the petition is here.

2010. December 1. NIH Director Francis Collins rejects the Fabrazyme march-in request filed by three Fabry disease patients. A cover letter to this decision, sent by March Rohrbaugh, Director of the NIH Office of Technology Transfer, to the attorney for the Fabry patients is available here.

2012. October 25. AMSA, KEI, PIRG, and UAEM asks the NIH Director Francis Collins to use march-in rights and royalty-free rights over patents related to ritonavir, a HIV drug marketed by Abbott under the brand name Novir.

2013. March 18. The NIH held a conference call with AMSA, KEI, PIRG, and UAEM regarding their October 25, 2012, march-in and royalty free request over patents related to HIV drug ritonavir.

2013. July 18. Senator Patrick Leahy, Chair of the Senate Judiciary Committee, urged the NIH Director Francis Collins “to consider using march-in rights under the Bayh-Dole Act to ensure access to genetic testing for breast and ovarian cancer.”

2013. November 1. The NIH Director Francis Collins rejects the ritonavir march-in and royalty-free request filed by AMSA, KEI, PIRG, and UAEM on October 25, 2012.

2016. January 11. 51 members of Congress led by Congressman Lloyd Doggett asks the HHS Secretary Sylvia Mathews Burwell and NIH Director Francis Collins to use march-in rights to rein in high drug prices.

2016. January 14. KEI and UACT submit a march-in and royalty-free rights request to the HHS Secretary Sylvia Mathews Burwell, DoD Secretary Ashton Carter, and the NIH Director Francis Collins over patents related to enzalutamide, a prostate cancer drug marketed under the brand name Xtandi by the Japanese pharmaceutical company Astellas.

2016. March 7. Congressman Lloyd Doggett issued a statement in support of the January 14, 2016, march-in request over prostate cancer drug Xtandi.

2016. March 28. Six Senators and six members of the House of Representatives send a letter to the NIH calling for an “open and transparent public hearing” to discuss the Xtandi march-in request filed by KEI and UACT on January 14, 2016.

2016. June 20. NIH Director Francis Collins rejects the Xtandi march-in and royalty-free request filed by KEI and UACT on January 14, 2016.

2017. April 29. KEI and UACT appealed the NIH Xtandi march-in and royalty-free decision to the HHS Secretary Tom Price, requesting that the Trump Administration reevaluate the January 14, 2016 request.

2017. June 7. NIH Director Francis Collins rejects the Xtandi march-in and royalty-free appeal filed by KEI and UACT on April 29, 2017, despite an explicit request that the appeal not be fielded by his office.

2017. July 17. The Senate Armed Services Committee unanimously approves a Directive that links exclusive patent rights to the prices of drugs, vaccines and other medical technologies that are based upon DoD-funded inventions. The text of the Directive is available here and follows.

Licensing of federally owned medical inventions

The committee directs the Department of Defense (DOD) to exercise its rights under sections 209(d)(1) or 203 of title 35, United States Code, to authorize third parties to use inventions that benefited from DOD funding whenever the price of a drug, vaccine, or other medical technology is higher in the United States than the median price charged in the seven largest economies that have a per capita income at least half the per capita income of the United States

2017. September 14. KEI submit a march-in and royalty-free request to Andrew Bremberg, an Assistant to the President and the Director of the Domestic Policy Council at the White House, and Keagan Lenihan, a Senior Adviser to HHS Secretary Tom Price, over patents related to daclizumab, a multiple sclerosis drug co-marketed by Biogen and AbbVie by under the brand name Zinbrytra.

2018. March 2. Biogen and Abbvie announced a voluntary withdrawal of Zinbryta from the market, noting concerns about the drug’s evolving benefit/risk profile.